||May 22, 2014
|Recall Event ID
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) - Product Code KPO
||Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle
Part Number: 08-4000-LB
The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
|| Lot Numbers (49 lots) recalled on 4/10/14:
Expanded Recall (9 lots):
|Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham, Massachusetts 02451-1521
|Naturalyte Liquid Bicarbonate maybe contaminated
|OTHER/UNDETERMINED: Under Investigation by the firm
||Fresenius Medical Care North America issued an Urgent Medical Device Recall Letter dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately and determine whether they have any of the affected parts on hand. If customers have the affected product, they were instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to Fresenius Medical Care Renal Therapies Group, LLC (FMC-RTG). Customers will be instructed to contact their Fresenius Medical Care Technical Services Team for instructions on how to return the recalled product. Firm will also conduct 100% telephone calls. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188.
Fresenius Medical Care sent an Urgent Expanded Medical Device Recall letter on May 1, 2014 for 9 additional lots.
Customers were instructed to complete and return the attached FAX BACK FORM to confirm that they have received the notice and to indicate whether or not they have the affected product in their possession.
For questions regarding this recall call 800-662-1237.
Firm issued Press on 5/21/14.
|Quantity in Commerce
||Worldwide Distribution - USA (nationwide) and Canada.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = KPO and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA